Operations Manager Bioprocess

at  Johnson Johnson

Johnson & Johnson is currently seeking Operations Manager Bioprocess to join our Johnson & Johnson Innovative Medicine Supply Chain organization located in Wilson, North Carolina.
While this role will ultimately support the site operations located in Wilson NC, this role will also be required to support the project phase across both design & construction. For the project design phase, the role will require you to be present with our design teams in the Greater Philadelphia region. Once the design phase is completed, this role will support the construction and operational start-up of the site. For this, you will be required to be on site in Wilson, NC. Based on your current location the hiring team will work with you to determine travel and relocation arrangements. In steady state, we expect travel to be less than 10%.
J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J&J’s significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
This Operations Manager Bioprocess is responsible for Media preparation, Buffer preparation, Column Pack and Equipment preparation operations as well as execution of company strategies in these areas. Provides leadership and direction for the manufacturing resources and activities to maximize quality, safety, and reliability. Partner with all support functions in the execution of meeting the production schedule, as well as identification and on-time completion of Operations projects/initiatives. Leads the Bioprocess organization in continuous improvement initiatives and capabilities. Accountable for achieving production targets while maintaining cost controls and compliance.

Key Responsibilities:

• Manage all activities within the Operations function in compliance with corporate, cGMP, EHS, and other regulatory requirements.
• Ensure that all activities within the Operations function are planned and executed to meet business needs, customer needs and the Operations schedule.
• Responsibility for managing resources within the Operations function.
• Providing leadership and direction to colleagues within the Operations function.
• Promote a culture of continuous improvement and open communication.
• Ensure that personnel are recruited and trained to support activities in line with business needs and site recruitment plan.
• Support Commissioning, Qualification, Validation and Technical Support activities related to the Operations function.
• Lead by example and strive to perform to high standards at all times in compliance with Credo and Leadership Behaviors. Act as a role model for all colleagues within the Operations department.
• Responsible and accountable for assuring the safe accomplishment of job activities in the Operations function and following good environmental practices and procedures. Commit to and demonstrate safe behavior in every activity.
• Providing leadership and direction to colleagues within the Operations function to ensure that goals, targets and expectations are communicated clearly.
• Respond to all concerns/issues raised by colleagues in an appropriate and timely manner.
• Translate business cascade goals into departmental and individual goals and clearly communicate goals to team.
• Monitor Operations, quality and EHS metrics/KPIs to ensure that departmental goals and targets are met.
• Provide coaching and feedback to team and individuals to enable them to perform effectively.
• Promote a culture of continuous improvement and open communication. Listen to, and involve colleagues in departmental decisions, goal setting etc. Seek feedback from colleagues to ensure that needs are being met and to ensure proper focus of resources.
• Recognize and respond to sources of change and manage change effectively. Promote a culture where change is viewed with a positive outlook.
• Completion of assigned tasks/projects/activities to support manufacture of quality biomedicines in accordance with cGMP and EHS requirements.
• Directly responsible person during internal and external audits (e.g. Compliance audit, Internal audit) and able to articulate and walk auditors through all processes in detail.
• Ensuring that colleagues within the Operations function are provided with appropriate training to perform their assigned duties to meet the business needs and regulatory requirements.
• Pursue opportunities to develop colleagues within Operations function.

Key Business Result:

• Customer Service Levels / OTS / OTD / OTIF / LIFR
• Inventory KPIs
• Quality - Critical Observations / Field Escalations / CAPA Closure
• Cost Improvement plans
• EHS&S - Good Saves, Significant Good Saves, Lost Working Days

QUALIFICATIONS

Required:

• B.S. degree in engineering, science or an IT discipline
• A minimum of 6 years of relevant experience in a manufacturing GMP environment, biopharmaceutical or pharmaceutical industry Extensive people management and leadership experience, including developing colleagues within operations.
• Strong interpersonal skills to build productive relationships, collaborate effectively, and work well within a team while treating others with dignity and respect.
• Flexibility and adaptability in a dynamic supply chain environment, with the ability to act quickly and with accountability to meet organizational goals.
• Cultural sensitivity and ability to thrive in a multi-cultural and matrixed environment.
• Strong enterprise awareness, enabling informed decisions that align with organizational priorities.
• Customer-focused and results-driven, with a clear understanding of how your work impacts the enterprise, leading to effective decision-making and prioritization.
• Experience in bioprocessing and managing audits.
• Extensive GMP compliance experience in pharmaceutical manufacturing.
• Knowledge of FDA/EMEA regulatory requirements related to biologics and/or pharmaceuticals.
• Maintain high ethical standards and integrity through Credo-based actions.
• Facilitate continuous improvement and innovation, challenging the status quo to drive positive change.
• Work as a strategic partner with all departments across the company.
• Hold yourself accountable for compliant and flawless execution.
• Advanced proficiency in English (speaking, reading, and writing).

Preferred:

• Experience of Media & Buffer preparation in an Operations environment.
• Experience of Microsoft Word Excel and Outlook.
• Experience of DCS (e.g Delta V), SCADA and PLC systems.
• Experience of SAP or other business systems.
• Experience in Cleaning and Sterilization
• Experience of Autoclaves and Sterilization.

This job posting is anticipated to close on 10/20/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

• Vacation – up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
• Holiday pay, including Floating Holidays – up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

Additional information can be found through the link below.
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com

• Manage all activities within the Operations function in compliance with corporate, cGMP, EHS, and other regulatory requirements.
• Ensure that all activities within the Operations function are planned and executed to meet business needs, customer needs and the Operations schedule.
• Responsibility for managing resources within the Operations function.
• Providing leadership and direction to colleagues within the Operations function.
• Promote a culture of continuous improvement and open communication.
• Ensure that personnel are recruited and trained to support activities in line with business needs and site recruitment plan.
• Support Commissioning, Qualification, Validation and Technical Support activities related to the Operations function.
• Lead by example and strive to perform to high standards at all times in compliance with Credo and Leadership Behaviors. Act as a role model for all colleagues within the Operations department.
• Responsible and accountable for assuring the safe accomplishment of job activities in the Operations function and following good environmental practices and procedures. Commit to and demonstrate safe behavior in every activity.
• Providing leadership and direction to colleagues within the Operations function to ensure that goals, targets and expectations are communicated clearly.
• Respond to all concerns/issues raised by colleagues in an appropriate and timely manner.
• Translate business cascade goals into departmental and individual goals and clearly communicate goals to team.
• Monitor Operations, quality and EHS metrics/KPIs to ensure that departmental goals and targets are met.
• Provide coaching and feedback to team and individuals to enable them to perform effectively.
• Promote a culture of continuous improvement and open communication. Listen to, and involve colleagues in departmental decisions, goal setting etc. Seek feedback from colleagues to ensure that needs are being met and to ensure proper focus of resources.
• Recognize and respond to sources of change and manage change effectively. Promote a culture where change is viewed with a positive outlook.
• Completion of assigned tasks/projects/activities to support manufacture of quality biomedicines in accordance with cGMP and EHS requirements.
• Directly responsible person during internal and external audits (e.g. Compliance audit, Internal audit) and able to articulate and walk auditors through all processes in detail.
• Ensuring that colleagues within the Operations function are provided with appropriate training to perform their assigned duties to meet the business needs and regulatory requirements.
• Pursue opportunities to develop colleagues within Operations function